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Day: December 27, 2020

Orphazyme provides regulatory update on arimoclomol for NPC

Written by Customer Service on . Posted in Public Companies.

­­Orphazyme A/SCompany announcement                                                                                       No. 73/2020Inside InformationCompany Registration No. 32266355Copenhagen, Denmark – December 27, 2020 – Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, announced today the U.S. Food and Drug Administration (FDA) has extended the review period of the New Drug Application (NDA) for arimoclomol for the treatment of Niemann-Pick Disease Type C (NPC) by a standard extension period of three months. This extension is necessary for the FDA to complete its review. The updated Prescription Drug User Fee Act (PDUFA) target action date is June 17, 2021. The FDA has confirmed the NDA remains under Priority Review,...

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